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Clinical Project Lead

5+ years
Not Disclosed
10 June 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Project Lead – Hyderabad, India

Job Type: Full-Time
Work Mode: On-site
Company: Sanofi


Job Summary

Sanofi is hiring a Clinical Project Lead for its Hyderabad site to manage rare disease registries and coordinate global clinical trial operations. This position plays a key role in overseeing end-to-end study execution, regulatory compliance, and cross-functional collaboration in a matrixed, international environment. With a strong focus on data integrity, safety, and GCP, this is an ideal opportunity for professionals experienced in clinical trial project management, especially in registry-based research.


Key Responsibilities

  • Lead country-level oversight of rare disease registries from startup through close-out

  • Participate in country and site feasibility and selection with Registry and Medical Affairs teams

  • Ensure timely supply of trial documents and contracts for regulatory submissions

  • Supervise CRAs, monitor site visit reports, and maintain project tracking tools

  • Liaise with vendors for startup and onsite monitoring activities

  • Implement Corrective and Preventive Actions (CAPA) to ensure quality and audit readiness

  • Maintain and contribute to Trial Master File (TMF) compliance and documentation

  • Coordinate international data collection, liaise with Medical Affairs and Global Registry Teams

  • Lead stakeholder communication, performance tracking, and process optimization


Required Skills & Qualifications

  • Bachelor's/Master’s degree in Pharmacy, Life Sciences, or related scientific field

  • 5+ years of experience in clinical research, with 2+ years in project leadership

  • Strong knowledge of ICH-GCP, FDA regulations, and local clinical trial laws

  • Hands-on experience with EDC systems, CTMS, and data validation processes

  • Strong communication, stakeholder management, and cross-cultural collaboration skills

  • Excellent problem-solving, planning, and negotiation abilities

  • Familiarity with global registry operations and matrix environments

  • Project Management Certification is a plus

  • High proficiency in English (spoken and written)

  • Proficiency in Microsoft Office tools


Perks & Benefits

  • Opportunity to lead global registry operations in rare diseases

  • Work in an AI-powered, digitally transformed pharma ecosystem

  • Engage with cutting-edge clinical trial platforms and tools

  • Inclusive, diverse, and innovation-driven work culture

  • Attractive compensation (not disclosed in the listing)

  • Global exposure through collaboration with international teams

  • Training and leadership development programs


Company Description

Sanofi is a global leader in pharmaceuticals and biotechnology, committed to transforming medical science into therapeutic solutions for chronic diseases, immunology, and rare disorders. At Sanofi, science meets compassion to drive innovation in global healthcare.


Location & Work Mode

Location: Hyderabad, India
Work Mode: On-site
Travel: Required as per business needs


Call to Action

Are you ready to lead impactful registries and shape the future of rare disease research? Apply now to join Sanofi’s Clinical Research team and be part of a global mission to make better health a reality.

Apply Today at Sanofi Careers